What are the responsibilities and job description for the Microbiologist II position at Raland Compliance Partners?
Coordinates microbiological testing, release of product results. Support routine testing and for PQ validation protocols. Performs Microbiology review of test results. Reads and interprets microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. Reviews and approves environmental monitoring data and laboratory equipment and records.
Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
Must have education and/or experience suitable for work in a biopharmaceutical or pharmaceutical or medical device manufacturing or similar environment.
* Supports environmental monitoring program and routine testing for cleanrooms, compressed gas systems and water systems.
* Perform microbial excursion investigations required from routine environmental monitoring program and reports finding to affected stakeholders.
* Perform microbiological testing including but not limited to Bioburden, Growth Promotion, Gram Staining, Endotoxin testing and chemical analysis on water samples (total organic carbon and conductivity testing).
* Perform environmental monitoring program data base tracking and trending, data entry and quarterly reporting.
* Perform environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Manufacturing operations, QC, Sanitization, Facilities and QA).
* Perform test method validations in support of microbiology operations (e.g. Endotoxin and Bioburden Testing) and interpret the results.
* Solid understanding of international and domestic environmental monitoring, sterilization requirements
* Perform environmental monitoring risk assessments and performed qualifications as needed.
* Responsible for writing protocols and reports and assist in the execution of PQ validations of microbiology control systems.
* Support the executions of PQ and the writing protocol/reports for Micro PQ validations.
* Ensures all microbiological procedures reflect current practices and complies with current applicable standards.
* Write, revise, and update procedures as necessary to keep them up to date with current practice.
* Investigate deviations and out of specification (OOS) results. Performs risk assessments, CAPAs and Change Order Plans (COPs).
* Flexibility to perform other duties, as assigned, or as business needs require.
* Supports all tasks related to laboratory upkeeping and the environmental monitoring program.
* Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.
* Works and communicates effectively and professionally with others inside and outside the company
* Weekend work may be required as needed to meet production timeline schedules
Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.
Must have education and/or experience suitable for work in a biopharmaceutical or pharmaceutical or medical device manufacturing or similar environment.
* Supports environmental monitoring program and routine testing for cleanrooms, compressed gas systems and water systems.
* Perform microbial excursion investigations required from routine environmental monitoring program and reports finding to affected stakeholders.
* Perform microbiological testing including but not limited to Bioburden, Growth Promotion, Gram Staining, Endotoxin testing and chemical analysis on water samples (total organic carbon and conductivity testing).
* Perform environmental monitoring program data base tracking and trending, data entry and quarterly reporting.
* Perform environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Manufacturing operations, QC, Sanitization, Facilities and QA).
* Perform test method validations in support of microbiology operations (e.g. Endotoxin and Bioburden Testing) and interpret the results.
* Solid understanding of international and domestic environmental monitoring, sterilization requirements
* Perform environmental monitoring risk assessments and performed qualifications as needed.
* Responsible for writing protocols and reports and assist in the execution of PQ validations of microbiology control systems.
* Support the executions of PQ and the writing protocol/reports for Micro PQ validations.
* Ensures all microbiological procedures reflect current practices and complies with current applicable standards.
* Write, revise, and update procedures as necessary to keep them up to date with current practice.
* Investigate deviations and out of specification (OOS) results. Performs risk assessments, CAPAs and Change Order Plans (COPs).
* Flexibility to perform other duties, as assigned, or as business needs require.
* Supports all tasks related to laboratory upkeeping and the environmental monitoring program.
* Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.
* Works and communicates effectively and professionally with others inside and outside the company
* Weekend work may be required as needed to meet production timeline schedules
A Minimum of 3 years of experience in a Microbiology Lab and Medical device industry experience
* knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices
* Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water.
* Microbiology, Biology or equivalent Bachelor's Science Degree (BS)
* Good documentation practices
* Detail oriented
* Proficient in laboratory techniques cGMP/cGLP and FDA/Industry regulations.
* Must have knowledge of the following standards and regulations: 21 CFR 820, International Organization for Standardization (ISO) 13485,14644 series and other risk guidance standards to create the processes and supporting documentation.
* Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)
* Must be able to work under pressure to meet deadlines on a fast pace environment.
* Ability to apply principals of scientific thinking to investigations, (OOS, OOT, CAPA, Risk Assessment)
* Must be able to organize and use time efficiently.
* Availity to work independently and as a team.
* knowledge of cGMPs, GLP, and FDA guidelines for control environments and sterilization of medical devices
* Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water.
* Microbiology, Biology or equivalent Bachelor's Science Degree (BS)
* Good documentation practices
* Detail oriented
* Proficient in laboratory techniques cGMP/cGLP and FDA/Industry regulations.
* Must have knowledge of the following standards and regulations: 21 CFR 820, International Organization for Standardization (ISO) 13485,14644 series and other risk guidance standards to create the processes and supporting documentation.
* Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)
* Must be able to work under pressure to meet deadlines on a fast pace environment.
* Ability to apply principals of scientific thinking to investigations, (OOS, OOT, CAPA, Risk Assessment)
* Must be able to organize and use time efficiently.
* Availity to work independently and as a team.
Please note:
This is not a Corp to Corp opportunity
We are not sponsoring at this time
